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Defining the Study Cohort: Inclusion and Exclusion Criteria

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Success in Academic Surgery: Clinical Trials

Part of the book series: Success in Academic Surgery ((SIAS))

Abstract

A study cohort is a group of individuals with common characteristics who are initially defined and composed, then examined or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific eligibility criteria. Inclusion criteria and exclusion criteria together determine who is eligible to participate in the study. These selection or eligibility criteria are ascertained during the design phase of the study, with the study goals of the clinical trial in mind. Hence, establishing eligibility criteria primarily requires the precise definition of the primary and secondary study outcomes, which provides guidance for the sample size of the clinical trial that is required to detect a significant difference between the study intervention and control group. The eligibility criteria should be sufficiently narrow to ensure internal study validity, but sufficiently broad to allow for generalizability of the study results to the general population. In addition, eligibility criteria must be chosen carefully to allow for the feasible recruitment of study subjects into the clinical trial and must meet ethical criteria established by the National Institutes of Health (NIH).

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Author information

Authors and Affiliations

  1. Division of Transplantation, Department of Surgery, Northwestern University Transplant Outcomes Research Collaborative (NUTORC), 676 N. St. Clair Street, Suite 1900, Chicago, IL, 60611, USA

    Lisa M. McElroy MD & Daniela P. Ladner MD, MPH

  2. Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Lisa M. McElroy MD & Daniela P. Ladner MD, MPH

Authors
  1. Lisa M. McElroy MD
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  2. Daniela P. Ladner MD, MPH
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Corresponding author

Correspondence to Daniela P. Ladner MD, MPH .

Editor information

Editors and Affiliations

  1. Department of Surgery, Johns Hopkins, Baltimore, USA

    Timothy M. Pawlik

  2. Department of Surgery,, Duke University School of Medicine,, Durham, North Carolina, USA

    Julie A. Sosa

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© 2014 Springer-Verlag London

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McElroy, L.M., Ladner, D.P. (2014). Defining the Study Cohort: Inclusion and Exclusion Criteria. In: Pawlik, T., Sosa, J. (eds) Success in Academic Surgery: Clinical Trials. Success in Academic Surgery. Springer, London. https://doi.org/10.1007/978-1-4471-4679-7_11

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  • DOI: https://doi.org/10.1007/978-1-4471-4679-7_11

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  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4678-0

  • Online ISBN: 978-1-4471-4679-7

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